The FDA has issued a complete response letter (CRL) regarding the new drug application for CCP-07 (Vernalis/Tris Pharma), an extended-release cough-and-cold medication. A CRL is issued when the FDA has completed its review of a new drug application and questions remain that preclude the application’s approval at that time.
The CRL for CCP-07 did not raise concerns with the drug’s formulation or pharmacokinetic profile but identified outstanding items that need to be addressed before the application can be resubmitted and approved. Vernalis said it plans to resubmit its application as soon as possible. The company offered no further details.
Under an exclusive licensing and collaboration agreement between Vernalis and Tris Pharma, announced in February 2012, Tris is developing up to six extended-release equivalents to existing immediate-release prescription cough-and-cold treatments for the U.S. market. CCP-07 was the second product from this pipeline to be accepted for FDA review.
Sources: Vernalis; April 21, 2017; and Vernalis; September 6, 2016.